Trial · NCT04495283
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Summed Pain Intensity (SPI) Between Group A and Group C | 0 to 48 hours | The Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment group to which they were randomized. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Summed Pain Intensity (SPI) Compared Between Group A and Group B | 0 to 48 hours | The Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment group to which they were randomized. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Summed Pain Intensity (SPI) Assessed by Numeric Rating Scale From Hour 0 to Hour 12 (SPI0-12), Hour 12 to Hour 24 (SPI12-24), and Hour 24 to Hour 48 (SPI24-48). | 0, 12, 24, 48 hours | The Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment group to which they were randomized. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Summed Pain Intensity (SPI) Assessed by Numeric Rating Scale Over Time | 0, 1, 2, 4, 6, 8, 10 ,12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, and 48 hours | The Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment group to which they were randomized. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Treatment-Related Adverse Events (TRAE) | 7 days | The Safety Analysis Set included all subjects who received any amount of study drug (APAP + PGB, APAP, or placebo), whether or not they were prematurely withdrawn from the study. The Safety Analysis Set was used for the summaries and listings of all safety assessments. Subjects were analyzed according to treatment received | participants | NUMBER |
| SECONDARY | Percentage of Participants Who Were Opioid Free Over Time | 12 to 48 hours | The Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment group to which they were randomized. | percentage of participants | NUMBER |
| SECONDARY | Total Consumption of Opioid Rescue Medication Through 24 Hours and 48 Hours | 24 hours and 48 hours | The Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment group to which they were randomized. | oral morphine equivalents | MEAN |
| SECONDARY | Total Consumption of Rescue Medication | 7 days | The Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment group to which they were randomized. | oral morphine equivalents | MEAN |
| SECONDARY | Time to First Use of Rescue Medication From Hour 0 | 7 days | The Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment group to which they were randomized. | hours | MEDIAN |
| SECONDARY | Percentage of Participants Who Used Rescue Medication | 7 days | The Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment group to which they were randomized. | percentage of participants | NUMBER |
| SECONDARY | Patient Global Assessment of Pain | 48 hours | The Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment group to which they were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Observed Concentration for PGB and APAP | Pre-infusion (at least 3.0 minutes before the start of the first infusion) and at 0.5, 1.5, 6.0, 8.0, 12.0, 16.0, 18.0, 24.0, 30.0, 32.0, 36.0, 40.0, 42.0, and 48 hours post-infusion | The PK Analysis Set included all randomized subjects who received any amount of study drug, had no protocol deviations affecting the pharmacokinetic (PK) variables, and had sufficient data collected to allow evaluation of least one PK parameter (minimum plasma concentration of the drug \[Cmin\], Cmax, or both). Subjects were analyzed according to treatment received. All PK analyses were performed using the PK Analysis Set | nanogram per milliliter (ng/ml) | GEOMETRIC_MEAN |
| SECONDARY | Minimum Observed Concentration for PGB and APAP | Pre-infusion (at least 3.0 minutes before the start of the first infusion) and at 0.5, 1.5, 6.0, 8.0, 12.0, 16.0, 18.0, 24.0, 30.0, 32.0, 36.0, 40.0, 42.0, and 48 hours post-infusion | The PK Analysis Set included all randomized subjects who received any amount of study drug, had no protocol deviations affecting the PK variables, and had sufficient data collected to allow evaluation of least one PK parameter (minimum plasma concentration of the drug \[Cmin\], Cmax, or both). Subjects were analyzed according to treatment received. All PK analyses were performed using the PK Analysis Set | nanogram per milliliter (ng/ml) | GEOMETRIC_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT04495283/outcomes